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Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution (PRO-230)

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Atropine Sulfate
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being clinically healthy
  • Ability to voluntarily sign an informed consent form (ICF).
  • Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
  • Age between 18 and 35.
  • Absence of history of contact lens use.
  • Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
  • Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
  • Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
  • Presenting vital signs within normal parameters.
  • Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria:

  • Using any kind of ophthalmic topical products.
  • Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
  • Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
  • For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
  • Having participated in any clinical study 90 days prior to the inclusion in this study.
  • Having participated in this clinical study.
  • History of any chronic degenerative disease, including diabetes and hypertension.
  • Presenting active inflammatory or infectious diseases when entering this study.
  • Presenting unresolved lesions or trauma when entering this study.
  • History of any ocular surgery.
  • History of any surgery, non-ocular, within the previous 3 months of entering this studies.
  • Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PRO-230

    Arm Description

    Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days.

    Outcomes

    Primary Outcome Measures

    Incidence of unexpected adverse events
    The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
    Incidence of photophobia
    The number of cases of photophobia.

    Secondary Outcome Measures

    Pupillary Diameter
    Change of pupillary diameter after exposure to the investigation product.
    Incidence of expected adverse events
    The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.
    Measurement of the change in best near corrected visual acuity (BNCVA)
    The change in BNCVA after exposure to investigation product, compared to basal value.

    Full Information

    First Posted
    July 28, 2022
    Last Updated
    December 26, 2022
    Sponsor
    Laboratorios Sophia S.A de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05481489
    Brief Title
    Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution
    Acronym
    PRO-230
    Official Title
    Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratorios Sophia S.A de C.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)
    Detailed Description
    A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire. The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    Phase I, non comparative, open, unicentric.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRO-230
    Arm Type
    Experimental
    Arm Description
    Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine Sulfate
    Intervention Description
    Atropine Sulfate 0.05% Ophthalmic Solution
    Primary Outcome Measure Information:
    Title
    Incidence of unexpected adverse events
    Description
    The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
    Time Frame
    Through Day 21 ± 1 (Safety Call)
    Title
    Incidence of photophobia
    Description
    The number of cases of photophobia.
    Time Frame
    Through Day 21 ± 1 (Safety Call)
    Secondary Outcome Measure Information:
    Title
    Pupillary Diameter
    Description
    Change of pupillary diameter after exposure to the investigation product.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
    Title
    Incidence of expected adverse events
    Description
    The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.
    Time Frame
    Through Day 21 ± 1 (Safety Call)
    Title
    Measurement of the change in best near corrected visual acuity (BNCVA)
    Description
    The change in BNCVA after exposure to investigation product, compared to basal value.
    Time Frame
    Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
    Other Pre-specified Outcome Measures:
    Title
    Measurement of the change in best corrected visual acuity (BCVA)
    Description
    The change in BCVA after exposure to investigation product, compared to basal value.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
    Title
    Changes in intraocular pressure (IOP)
    Description
    The change in IOP after exposure to investigation product, compared to basal value.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
    Title
    Incidence of corneal and conjunctival staining
    Description
    Presence of corneal and conjunctival staining with fluorescein and lissamine green after exposure to investigation product.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
    Title
    Measurement of vital signs (blood pressure)
    Description
    The change in blood pressure after exposure to investigation product, compared to basal value.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
    Title
    Measurement of vital signs (heart rate)
    Description
    The change in heart rate after exposure to investigation product, compared to basal value.
    Time Frame
    Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
    Title
    Value of the ocular comfort index (OCI) questionnaire
    Description
    The change ocular comfort index (OCI) questionnaire results after exposure to investigation product, compared to basal value.
    Time Frame
    Days: 1 (Basal Visit), 16 ± 1 (Final Visit)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being clinically healthy Ability to voluntarily sign an informed consent form (ICF). Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study. Age between 18 and 35. Absence of history of contact lens use. Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study. Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes. Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes. Presenting vital signs within normal parameters. Presenting an IOP ≥10 and ≤ 21 mmHg Exclusion Criteria: Using any kind of ophthalmic topical products. Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents. Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study. Having participated in any clinical study 90 days prior to the inclusion in this study. Having participated in this clinical study. History of any chronic degenerative disease, including diabetes and hypertension. Presenting active inflammatory or infectious diseases when entering this study. Presenting unresolved lesions or trauma when entering this study. History of any ocular surgery. History of any surgery, non-ocular, within the previous 3 months of entering this studies. Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alejandra Sánchez Rios, MD
    Phone
    +52 3330014200
    Ext
    1190
    Email
    alejandra.sanchez@sophia.com.mx

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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